Amgen

Executive Director, PrePivotal Drug Product Technologies

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Apr 06, 2021
Ref
R-115674
Required Education
Doctorate/PHD/MD
Position Type
Full time
HOW MIGHT YOU DEFY IMAGINATION?

At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission-to serve patients-has driven our status as one of the world's preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.

Executive Director, PrePivotal Drug Product Technologies

Live

What you will do

Let's do this. Let's change the world. In this vital role you will lead Amgen's prepivotal phase drug product technologies organization. You will be accountable for advancing the early stage biologics/synthetics portfolio to the clinic with line of sight to successful commercialization of products that are patient centric, differentiated from the competition, and better serving to an expanded patient population. Specifically, the successful candidate will:
  • Oversee a team responsible for First-in-Human drug product development for biologics/synthetics portfolio and small molecule process scale-up and manufacturing for clinical trials
  • Influence molecule selection and advancement of therapeutic candidates that can meet the Target Product Profile and preferred product presentation
  • Establish and maintain partnership agreements with counterparts across R&D and Operations, including across Process Development, Quality, Regulatory, Clinical Supply and Commercial Manufacturing
  • Drive alignment of drug product development practices and initiatives across sites and phases of development
  • Apply data science to leverage prior knowledge within Drug Product Technologies
  • Identify and implement innovative solutions and technologies to resolve complex problems and drive continuous improvement in drug product development.
  • Manage a high performing team and provide creative strategies to maximize team engagement and ensure team reaches full potential.
  • Provide oversight and leadership of innovation in molecule/protein engineering, high throughput/automation, optimizing patient experience, and novel drug delivery technologies
  • Serve as member of the Drug Product Technology (DPT) leadership team and extended Process Development leadership team utilizing network thinking and innovative approaches to advance the drug product organizational capabilities


Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Executive-level professional we seek is a leader with these qualifications.

Basic Qualifications:
  • Doctorate Degree & 6 years of Pharmaceutics, Formulation or Process Development experience OR
  • Master's Degree & 10 years of Pharmaceutics, Formulation or Process Development experience OR
  • Bachelor's Degree & 12 years of Pharmaceutics, Formulation or Process Development experience AND
  • 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources


Preferred Qualifications:
  • Ph.D. or equivalent in Biochemistry, Chemistry, Pharmaceutical Sciences, Chemical Engineering, Biological Sciences or related major and 14+ years of relevant experience in the pharmaceutical or related industry which includes leadership of scientific project teams and successful leadership of drug product project groups
  • Direct experience with formulation and drug product process development
  • Understanding and applied knowledge of regulatory requirements for the pharmaceutical industry (e.g. FDA, ICH, and USP guidelines)
  • Knowledge of pharmaceutical science, analytical chemistry, and protein stability
  • Knowledge of chemical process development of drug product
  • Knowledge of drug product process scale-up and aseptic manufacturing
  • Knowledge of novel drug delivery technologies


Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
  • Clear and disciplined strategic vision for the future that leverages superior-quality products, operational excellence and top-shelf-talent
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits


Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.